Process Engineer
ACL Digital
Job Title: Engineer
Duration: 06+ Months
Location: Thousand Oaks, CA
Pay Rate: $46/hr on w2
Description:
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.
The Engineer will apply harvest and purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.
JOB RESPONSIBILITIES:
Under guidance of senior staff, the Engineer performs the following:
Transfer purification drug substance processes and performs process improvements from the laboratory into the manufacturing facility
Provide technical support for successful scale-up, transfer of process technology, and for clinical and /or commercial manufacruring operation
Offer process validation support for late stage commercial processes
provide routine process monitoring and troubleshooting
Execute data trending and statistical process analysis
Support technical direction for process related deviations, CAPAs and change controls
Identify and support process related operational excellence opportunities
represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory
PREFERRED QUALIFICATIONS:
Master's Degree in Chemical or Biochemical Engineering
1+ Years of Process Engineering Experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
Background in biologics tech transfer into commercial facilities
Purification process knowledge
Knowledge of purification processes/equipment; scale up factors from chromatography, UF/DF, process deviations, raw materials to growth and quality attributes
Strong capability of analysis, troubleshooting and problem solving
Ability to develop and follow detailed protocols
Independently motivated with ability to multi-task and work in teams
Excellent written and verbal communication skills with technical writing and presentation experience
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